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JXO — Enzyme Immunoassay, Cocaine Class II

FDA Device Classification

Classification Details

Product Code
JXO
Device Class
Class II
Regulation Number
862.3250
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K201228psychemedics corporationPsychemedics Homogeneous Enzyme Immunoassay for Cocaine in HairJune 25, 2021
K111925psychemedicsPSYCHEMEDICS COCAINE EIAMay 1, 2012
K923314serexAUTOMATES COMA PLUS COCAINE METABOLITE ASSAYAugust 24, 1992
K921140solarcare technologies corpSTC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIAAugust 20, 1992
K915785solarcare technologies corpSTC DIAGNOSTICS BENZOYLECGONINE EIAMarch 11, 1992
K913737instrumentation laboratoryIL TEST(TM) COCAINEDecember 3, 1991